Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II variation application for trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.

Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca

Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). This application is based on data from the DESTINY-Breast03 phase 3 trial presented at the 2021 European Society for Medical Oncology (ESMO) Congress.

Breast cancer is the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally. In Europe, approximately 531,000 cases of breast cancer are diagnosed annually. Approximately one in five cases of breast cancer are considered HER2 positive. Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression. More treatment options are needed to further delay progression and extend survival.

“We are excited to have submitted a second application this year seeking approval for trastuzumab deruxtecan for a potential third indication in Europe,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “With this specific application, we look forward to working closely with the EMA to support the review of trastuzumab deruxtecan to be used in an earlier setting for patients with HER2 positive metastatic breast cancer.”